Clinical Research Coordinator – Nephrology Full-time

Clinical Research Coordinator

This position has a term length of 1 year plus 1 day.

Location – This role is in-person at North Campus Edmonton.

This is a new 1.0 FTE fixed term Clinical Research Coordinator position that reports to a Principal Investigator (PI), Dr Neesh Pannu, with the Kidney Health Research Group within the Department of Medicine at University of Alberta in Edmonton, Alberta. The Clinical Research Coordinator is a critical and dynamic role in the coordination and supervision of clinical research. They are expected to develop, execute, coordinate, and evaluate multiple clinical research and trial processes within our program. The schedule may not be fixed days or set hours and may require flexible hours during the day and evenings to accommodate study and patient schedules. The Clinical Research Coordinator works closely with Principal investigators, Research Manager, Sponsor representatives, clinical research staff, Institutional departments and research participants in the conduct of a variety of clinical research studies. The Clinical Research Coordinator is self-directed and requires minimal supervision to work with multiple competing priorities to meet deadlines and objectives for each project. Resourceful, creative, and innovative problem solving is key to this position. The successful candidate will also have demonstrated analytical abilities that will be applied to various research and development areas with a moderate to high impact of error. The role will support the development and maintenance of relationships among various research members, staff, organizations, stakeholders (i.e. Alberta Health Services/ Acute Care Alberta, Alberta Precision Laboratories, Research pharmacy, Diagnostics departments, Clinical Trials Office) and will be a mentor and supervisor to members of the team. Must have own transportation to be able to travel between study locations at various hospital sites within the city on a weekly basis.

Responsibilities

The Clinical Research Coordinator will work on a variety of clinical and health research trials, projects, initiatives, that will routinely involve managing multiple competing concurrent tasks. Competent decision making, precise, accurate attention to detail and strong problem-solving skills will be essential in performing the job duties. The Clinical Research Coordinator will be responsible for the coordination, compliance and implementation of study protocols, standard operating procedures, internal processes, Good Clinical Practices, Health Canada Part C – Division 5 and FDA regulations where applicable in the conduct of research for the Department of Medicine, division of Nephrology.

Accountabilities for this position fall into two key areas:

• clinical research coordination
• communication, interaction, compliance monitoring

Clinical Research Coordination (80%)

• Responsible for the successful coordination work of one or more simultaneous studies in accordance with protocols, applicable contracts, budget requirements, and in compliance with all policies, procedures, and guidelines of the research group, the University of Alberta, applicable regulatory bodies, and the research ethics board.
• Demonstrates capable knowledge in all aspects of clinical and pragmatic clinical trial coordination including but not limited to screening, informed consent process, randomization, IP dispensation, vital sign assessment and follow-up of study subjects, working within electronic clinical information systems, data management, completing case report forms (CRF's), project closure activities, monitoring, and audits and other protocol specific tasks as delegated by the PI.
• Prepares study files as delegated by the PI. These study materials include but are not limited to regulatory binders, informed consent documents, case report forms (CRF's), enrollment logs, drug/device accountability logs, and study specific source documents.
• Reporting to the Principal Investigator and research manager, monitor day to day research activities, report on study status, and deliverables on a regular basis.
• Responsible for reporting of adverse and serious adverse events according to the study protocol and in accordance with local ethics board, regulatory agencies, and sponsor requirements
• Ensure required confidentiality agreements are in place where appropriate.
• Monitor and maintain stock supplies of clinical trial study drug and clinical trial supplies applicable to each study/research protocol.
• Arranges the secure storage of all study documents that will be maintained according to University of Alberta policy, Health Canada, FDA or for the Sponsor contracted length of time.
• Responsible for delegated tasks related to research protocols (review, feasibility), ethics submissions (including but not limited to – applications, modifications, renewals, deviations, closures) and all research contract and vendor agreements.
• Assists in evaluating and revising recruitment plans; study contract process functions; vendor contracts and maintaining electronic data base platform.
• Assists in performing feasibility assessments of patient population and helps to analyze specific study protocol inclusion / exclusion criteria against standards of care at the site.
• Demonstrates understanding and applicable training in the access, use and disclosure of personal and health related information in accordance with federal/provincial regulations, University of Alberta, Ethics boards, and Sponsoring agencies.
• Assists with the development and revisions in the application and maintenance of study specific standard operating procedures (SOP's) and procedures related to research activities for each of the projects delegated to them.
• Coordinates and cooperates with the University of Alberta, Department of Medicine, and external entities (i.e. Health Canada, FDA, Industry Sponsors) in compliance and monitoring efforts related to clinical trials.
• Knowledge and experience of various department of Medicine functions and AHS research administrative approval processes.
• Attends investigator meetings as required or requested by PI.
• Assists in the registration (if required) of the study (i.e., ClinicalTrials.gov) and maintains current information on the site.
• Maintains effective and ongoing communication with Sponsor, research participant and PI during the study.
• Performs miscellaneous job-related duties as assigned.

Communication / Interaction / Compliance monitoring (20%)

• Communicates and works with internal and external research parties, along with the PI and research manager.
• Ensures the projects and research activities adhere to ethical guidelines and legal requirements for research.
• Implements clinical study protocols, monitor daily study activity, and prepare reports to PI and research manager as appropriate.
• Establishes and maintains good working relationships with all team members and external parties.
• Works with PI and research manager to develop communication strategies and tools and to ensure applicable clinical research communications are up to date and accurate.
• Accurate and timely preparation of relevant clinical trial progress reports and presentations, scientific writing assignments and grant applications.
• Provide support and assistance in a positive, open approach within the research team to foster the growth of team members to achieve success in all projects.
• Tact and diplomacy when dealing with and interacting with others.
• Promote the importance of teamwork and collaboration within the Kidney Health Research Group and work with other members of the team to achieve the best possible outcomes within the Kidney Health Research Group and those afflicted with kidney and chronic disease.

Qualifications

• Minimum of 5 years of relevant work experience in clinical trial research in an academic setting, and have a satisfactory understanding of health care delivery in both community and acute care settings.
• Bachelors degree in a related area is required.
• Master's or PhD degree in relevant fields or; a Registered Nurse possessing a BScN with an active CRNA designation are assets.
• Experience as a Research Coordinator is required.
• Previous experience coordinating multiple projects and deliverables with competing priorities/deadlines.
• Experience in a health research setting with researchers, practitioners and patient groups is an asset.
• Experience in nephrology-related care would be considered an asset.
• Certified Clinical Research Professional (CCRP) designation preferred.
• SPOR Pragmatic Clinical Trials certificate is an asset.
• Proven experience working with/on research protocols, ethics submissions, research agreements/contracts, financial reporting, project progress reporting, and scientific writing skills preferred.
• Demonstrated ability to interact and work with members of the research team with integrity, honesty and professionalism.
• Strong organizational, time management and problem-solving skills
• Ability to take initiative, set priorities, work independently and in a team environment.
• Strong interpersonal skills as well as effective written and oral communication skills
• Demonstrated commitment to accuracy and attention to detail.
• Demonstrated flexibility with work hours and assisting the research team to meet priorities/deadlines.
• Commitment to employing conflict management and negotiation skills
• Working knowledge and experience with ICH-GCP requirements, HIA, PIPA, FOIP, TCPS2, HC Div5, and FDA regulations preferred.